Status:
COMPLETED
PENTHROX™ in the Canadian Emergency Department (ED)
Lead Sponsor:
Purdue Pharma, Canada
Conditions:
Pain, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This Canadian, multi-centre, prospective, real world study is designed to evaluate the effectiveness of low dose methoxyflurane (MEOF) (PENTHROX™) for the treatment of moderate to severe pain associat...
Detailed Description
The study will assess the change in pain intensity over 20 minutes from start of administration of PENTHROX™ and will generate Real World Evidence in support of existing clinical trial data including ...
Eligibility Criteria
Inclusion
- Conscious adult patients: ≥ 18 years of age
- Moderate to severe pain associated with trauma (NRS0-10 ≥ 4) which is unlikely to require surgery/hospitalization, such as
- Musculoskeletal injuries and physical wounds
- Fractures
- Lacerations
- Burns
- Dislocations
- Contusions
- Injury due to foreign bodies
- Patient (and/or patient's authorized legal representative) should understand the nature of the study and provide written informed consent
- Patient is able to follow all study requirements and procedures and complete required questionnaires
Exclusion
- Multi-level trauma
- Women of child bearing potential who are pregnant or peri partum, including labour
- An altered level of consciousness, due to any cause, including head injury, drugs, or alcohol
- Clinically significant renal impairment
- A history of liver dysfunction after previous MEOF use or other halogenated anesthetics
- Hypersensitivity to MEOF or other halogenated anesthetics, or to butylated hydroxytoluene
- Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives
- Exacerbation of an underlying condition (i.e., chronic pain)
- Clinically evident or potential hemodynamic instability as per the opinion of the investigator
- Clinically evident respiratory impairment as per the opinion of the investigator
- Prior treatment with PENTHROX within 3 months
Key Trial Info
Start Date :
April 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2020
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT03868436
Start Date
April 8 2019
End Date
September 8 2020
Last Update
September 16 2021
Active Locations (6)
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1
Charles V Keating Emergency and Trauma Centre, QEII
Halifax, Nova Scotia, Canada, B3H3A7
2
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada, L4M 6M2
3
Markham Stouffville
Markham, Ontario, Canada, L3P 7P3
4
St. Joseph's Healthcare
Welland, Ontario, Canada, L3B4W6